cytarabine

Generic: cytarabine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cytarabine
Generic Name cytarabine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

cytarabine 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-120
Product ID 63323-120_88adbc49-b19d-44af-8f0b-a563bbb02aec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076512
Listing Expiration 2026-12-31
Marketing Start 2004-11-29

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323120
Hyphenated Format 63323-120

Supplemental Identifiers

RxCUI
249364
UPC
0363323120207
UNII
04079A1RDZ
NUI
N0000000233 N0000175595

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cytarabine (source: ndc)
Generic Name cytarabine (source: ndc)
Application Number ANDA076512 (source: ndc)
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-120-20 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cytarabine (100 mg/mL)

Linked Drug Pages (1)

Cytarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "88adbc49-b19d-44af-8f0b-a563bbb02aec", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0363323120207"], "unii": ["04079A1RDZ"], "rxcui": ["249364"], "spl_set_id": ["c4fdc56e-efd7-4825-a518-ef430b2b3df0"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-120-20", "marketing_start_date": "20041129"}], "brand_name": "Cytarabine", "product_id": "63323-120_88adbc49-b19d-44af-8f0b-a563bbb02aec", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-120", "generic_name": "CYTARABINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cytarabine", "active_ingredients": [{"name": "CYTARABINE", "strength": "100 mg/mL"}], "application_number": "ANDA076512", "marketing_category": "ANDA", "marketing_start_date": "20041129", "listing_expiration_date": "20261231"}